Medtronic, a global leader in healthcare technology, announced today that it has received CE (Conformité Européenne) Mark approval for several expanded indications for the treatment of coronary artery disease (CAD) with the Prevail™ paclitaxel-coated percutaneous transluminal coronary angioplasty (PTCA) balloon catheter, also known as a drug-coated balloon (DCB).

医疗器械领域的全球领导者美敦力公司今天宣布，其Prevail™紫杉醇涂层经皮冠状动脉腔内成形术（PTCA）球囊导管（也称为药物涂层球囊（DCB））已获得CE（欧洲合格认证）标志批准，用于治疗冠状动脉疾病（CAD）的多项扩展适应症。

The Prevail DCB now has the broadest range of CE Mark indications including bifurcation and is the only DCB indicated for treatment in patients with multivessel disease, acute coronary syndrome, and diabetes..

Prevail DCB现在拥有最广泛的CE标志适应症，包括分叉病变，并且是唯一被指定用于治疗多支血管病变、急性冠脉综合征和糖尿病患者的DCB。

CE Mark approval follows the Prevail DCB’s excellent performance in a large, real-world, complex patient population from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR). In a

CE标志的批准是基于Prevail DCB在瑞典冠状动脉造影和血管成形术注册中心（SCAAR）的大规模、真实世界、复杂患者群体中的出色表现。在一项

late-breaking clinical trial

晚期临床试验

, presented at Cardiovascular Research Technologies, the Prevail DCB demonstrated low event rates* at two years including 6.1% new myocardial infarction, 7.4% target lesion revascularization, and 0.8% target lesion definite thrombosis. In hybrid percutaneous coronary intervention (defined as DCB and drug-eluting stent in the same vessel), the study showed the Prevail DCB demonstrated numerically lower new myocardial infarction rates versus other DCBs..

在心血管研究技术大会上发表的研究显示，Prevail DCB 在两年内表现出较低的事件发生率*，包括6.1%的新发心肌梗死、7.4%的目标病变血运重建和0.8%的目标病变明确血栓形成。在混合型经皮冠状动脉介入治疗（定义为在同一血管中使用DCB和药物洗脱支架）中，研究表明，与其他DCB相比，Prevail DCB显示出数值上更低的新发心肌梗死率。

These results were confirmed for bifurcation patients in a subgroup analysis presented at EuroPCR this week. In bifurcation lesions, the Prevail DCB demonstrated low mortality and revascularization rates,

这些结果在本周于欧洲经皮心血管介入治疗大会（EuroPCR）上发表的亚组分析中得到了证实。在分叉病变中，Prevail DCB 展现了较低的死亡率和再血管化率。

with 2.3% new myocardial infarction, 2.8% target lesion revascularization, and 0% target lesion definite thrombosis at one year. The event rates were consistently low across the different bifurcation strategies and suggest the Prevail DCB is an effective treatment option for a variety of complex coronary lesions..

一年时，新发心肌梗死率为2.3%，靶病变血运重建率为2.8%，靶病变明确血栓形成率为0%。不同分叉策略下的事件率均保持较低水平，表明Prevail DCB是治疗各种复杂冠状动脉病变的有效选择。

“The Prevail DCB’s acute performance, clinical data, and expanded indications support the needs of physicians who treat increasingly complex patients. We are taking the same approach we've taken over the years with our drug-eluting stents,” said Jason Weidman, senior vice president and president of the Coronary & Renal Denervation business, part of the Cardiovascular Portfolio at Medtronic.

“Prevail DCB 的急性性能、临床数据和适应症的扩展满足了治疗日益复杂的患者的医生的需求。我们正在采取与多年来在药物洗脱支架上相同的策略，”美敦力心血管产品组合中冠状动脉及肾去神经业务的高级副总裁兼总裁 Jason Weidman 表示。

“By bringing real world clinical data to the forefront, we can expand use of the Prevail DCB in new patient populations. We look forward to helping even more physicians across the globe access the tools they need to give their patients best-in-class care.”.

“通过将真实世界的临床数据置于前沿，我们可以扩大Prevail DCB在新患者群体中的应用。我们期待帮助全球更多的医生获取他们所需的工具，为患者提供一流的护理。”

CAD affects more than 315 million people worldwide and is a condition in which arteries that support blood and oxygen to the heart become narrowed or blocked, most often because of plaque buildup.

冠心病影响着全球超过3.15亿人，这是一种为心脏提供血液和氧气的动脉变窄或堵塞的疾病，最常见原因是斑块堆积。

Drug-coated balloons are gaining traction globally as a treatment option for patients with CAD. As the clinical evidence landscape expands, physicians are using DCBs in a broader range of cases, including one of the fastest growing areas - bifurcation lesions.

药物涂层球囊正作为治疗冠心病患者的一种选择在全球范围内受到关注。随着临床证据的增多，医生们正在更广泛的病例中使用药物涂层球囊，其中包括增长最快的领域之一——分叉病变。

DCBs can simplify bifurcation procedures, which are often considered more challenging, by potentially reducing the number of stents when treating side branch disease while also promoting positive vessel remodeling.

药物涂层球囊可以简化通常被认为更具挑战性的分叉手术，因为在治疗侧支疾病时可能减少支架的数量，同时促进血管的正向重塑。

Prevail DCB provides superior deliverability, an effective antirestenotic drug formulation (paclitaxel), and sustainable long-term outcomes.

Prevail DCB提供了卓越的输送性能、有效的抗再狭窄药物配方（紫杉醇）以及可持续的长期效果。

It was launched in Europe in 2021 with indications for the treatment of de novo lesions, in-stent restenosis, and small vessel disease in the coronary arteries. Its differentiated FreePac™ coating has an extensive body of evidence in both coronary and peripheral artery disease with over 10 trials and 1,600 patients studied..

它于2021年在欧洲推出，用于治疗冠状动脉中的新生病变、支架内再狭窄和小血管疾病。其独特的FreePac™涂层在冠状动脉和外周动脉疾病中拥有大量证据支持，已有超过10项试验和1600名患者参与研究。

The Prevail DCB is commercially available in more than 80 countries globally and is limited to investigational use in the U.S. and Japan.

Prevail DCB 已在全球 80 多个国家实现商业供应，在美国和日本仅限于研究使用。

About Medtronic

美敦力公司简介

Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway, Ireland, is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across more than 150 countries.

大胆思考。更果敢的行动。我们是美敦力。美敦力公司总部位于爱尔兰戈尔韦，是全球领先的医疗技术公司，通过寻找和发现解决方案，大胆地应对人类面临的最具挑战性的健康问题。我们的使命——减轻病痛、恢复健康、延长生命——团结了遍布150多个国家的95,000多名充满热情的员工。

Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day.

我们的技术和疗法治疗70种健康状况，包括心脏设备、手术机器人、胰岛素泵、手术工具、患者监测系统等。凭借我们多样化的知识、无尽的好奇心和帮助所有需要帮助的人的愿望，我们提供了创新的技术，每秒、每小时、每一天都在改变两个人的生活。

Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic, visit .

期待我们带来更多精彩，因为我们致力于推动以洞察力为导向的护理、以人为本的体验，以及为我们的世界创造更好的结果。在我们所做的一切中，我们正在创造非凡。欲了解有关美敦力的更多信息，请访问。